COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Adalimumab (HUMIRA) AS AN ORPHAN DRUG
I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J(2) of the Regulations, designate Adalimumab (HUMIRA) as an orphan drug on 30 January 2015 for the treatment of paediatric Enthesitis-Related Arthritis (paediatric ERA).
The dose form of Adalimumab (HUMIRA) for this indication is solution for injection.
The sponsor of Adalimumab (HUMIRA) is Abbvie Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
30 January 2015